FDA Approves Lilly’s Forteo

FDA has approved a new use for Eli Lilly’s osteoporosis drug – Forteo [teriparatide (rDNA origin) injection]. The drug is to treat osteoporosis associated with sustained, systemic glucocorticoid therapy in men and women at high risk of fracture.

Reportedly, in the course of the FDA’s review of the new indication, Lilly provided data from a clinical study. Results showed that in patients with glucocorticoid-induced osteoporosis, Forteo increased bone mineral density from baseline to 18 months of treatment by 7.2% at the lumbar spine, 3.6% at the total hip, and 3.7% at the femoral neck.

Vladimir Kopernicky, medical director for Eli Lilly, said: The FDA’s decision provides these patients with a valuable treatment option for osteoporosis, which they may develop as a result of their sustained glucocorticoid use.